Electrical safety for the patient and staff in healthcare premises

In hospitals patient care is of paramount importance. So its the medical staffs task to ensure that patients are treated effectively and receive the highest level of care. But even a short power failure may expose patients to hazards or impair successful therapy or diagnosis. The IEC 60364-7-710:2002 is an internationally applied standard specifying the requirements for the electrical installations for medically used rooms. Introduction In hospitals and in medical locations outside hospitals, e.g. medical practices, the number of mainssupplied medical electrical equipment is steadily increasing. Therefore, not only is great importance attached to safe and secure power supply of equipment intended to be used for diagnosis and therapy but in particular to safe power supply of mains-supplied equipment intended to be used for life-saving and life-supporting measures which affect the health and safety of patients in case of failure or by current passing through the human body. The ensuing increased requirements for safe and secure power supply apply to all the electrical equipment used in hospitals and in particular for rooms like operating theatres, heart catheterisation rooms. High reliability and safety of electrical installations in this area means: ensuring high availability of electrical power supply selecting the appropriate protective measures against electric shock, particularly against electric shock under fault conditions creating a high level of electrical safety

The necessity of safe and secure power supply is undisputable. Electrical installations in medically used rooms should comply with state-of-the-art technology, because human lives deserve the best possible protection modern technology is able to provide. Classification of medical locations as per IEC 60364-7-710:2002 The particular requirements of IEC 60364-7-710:2002 apply to hospitals, private clinics, medical and dental practices, health care centres and dedicated medical rooms in the work place. It may be necessary to modify the existing electrical installation in accordance with this standard, when a change of utilization of the location occurs (e.g. intracardiac procedures). Medical locations are divided into 3 groups considering the application of medical technical equipment on the patient. 710.3.5 Group 0: Medical locations where no applied parts are intended to be used. 710.3.6 Group 1: Medical location where applied parts are intended to be used as follows: -externally -invasively to any part of the body, but not to the heart, except where 710.3.7 applies 710.3.7 Group 2: Medical location where applied parts are intended to be used in applications such as intracardiac procedures, operating theatres and vital treatment where discontinuity (failure) of the supply can cause danger to life Typical group 2 rooms e.g. are Anaesthetic rooms, Operating theatres, Intensive care rooms, Premature baby rooms The highest demands are made on electrical installations in group 2 medical locations because a failure of the power supply or currents higher than 10 A passing through the human body can lead to an immediate threat of danger to the life and limb of the patient.

Further, it should be mentioned that in view of the increasing requirements regarding the variety of communication and information systems used, the TN-C system is not allowed downstream the main distribution board (section 710.312.2). In order to avoid leakage currents, e.g. via conductive parts of the building, and potential differences, the use of the TN-S system is a must.

Protective measures in group 2 medical locations When specifying the protective measures for group 2 medical locations, the following aspects should be considered: the likelihood of a power supply failure the likelihood of defective devices the likelihood of direct or indirect contact the technical and economical possibilities the available figures based on experience

Both the aforementioned essential aspects and the requirements IEC of 60364-4-41 have been considered by the standard IEC 60364-7-710. Hence, as a basic principle only protective measures are to be applied that do not lead to disconnection respectively that do not cause hazards through high touch voltages in the event of a first fault. For circuits in group 2 medical locations, which are intended to be used to supply medical electrical equipment applied on patients, the IT system with insulation monitoring and indication is to be used. Amongst other things, the following protective goals can be achieved: no disconnection in case of a first fault small touch currents possibility of a sensitive insulation fault detection/indication high reliability of electrical installations which are kept in good working order

When operating an IT system it has to be taken into consideration that in the event of a first fault an initially unearthed system (IT system) turns into an earthed system (TN or TT system) and that a second fault leads to the tripping of an protective device and hence to disconnection. Practical experience, however, has clearly shown that the single-pole fault (first fault) is the most likely type of fault to occur (>90%) and therefore hazardous situations through a second fault are regarded as being very unlikely. Design of an unearthed power supply system (IT system) Where the power supply of group 2 medical locations is concerned, the unearthed power supply (IT system) with insulation monitoring and indication is a crucial factor. The basis for the IT system is a power source isolated against earth. In addition, a single-phase isolating transformer according to IEC 61558-2-15 is used with a rated power of 0.5 10 kVA as specified in IEC 60364-7-710, section 512.1.6. Further specifications are: secondary voltage of AC 250 V and a max. leakage current of 0.5 mA. The essential advantage of an IT system becomes obvious when a first fault occurs. Only a small current IF flows the value of which is determined by the system leakage capacitance CE. Hence, the tripping of a fuse is prevented, the power supply is not interrupted, the electrical installation can be kept in operation (Figure 1):

Figure 1: IT system with insulation monitoring

In group 2 medical locations, the medical IT system shall be used for circuits supplying electrical equipment and systems intended for life-support or surgical applications and other electrical equipment located in the patient environment excluding the following equipment: circuits for the supply of operating tables circuits for X-ray units circuits for large equipment with a rated power greater than 5 kVA circuits for non-critical electrical equipment (non life support).

This equipment can be supplied from a TN-S system with an RCD with a rated residual-operating current not exceeding 30 mA. Care shall be taken that the conventional touch voltage in the group2 location does not exceed 25 V (IEC 60364-7-710, section 413.1.1.1). Additionally it is recommended that TN-S systems are monitored to ensure the insulation level of all live conductors.

Monitoring of the insulation resistance According to IEC 60364-7-710, section 413.1.5, an IT system is to be equipped with an insulation monitoring device with the following additional requirements: the AC internal impedance shall be at least 100 k the test voltage shall not be greater than DC 25 V the test current shall, even under fault conditions, not be greater than 1 mA the response value shall be 50 k the indication shall take place, if the earth or wiring connection is lost.

For testing the insulation monitoring device a test button is provided directly at the device and in the alarm indicator and test combination. Connection monitoring is another important requirement which needs to be fulfilled. In this way interruptions in connecting leads to the system and to earth are immediately recognized and indicated. Insulation monitoring devices using the measuring principle of superimposed measuring DC voltage may initiate false alarms due to DC components. The reason for that is that in case of a fault these extraneous voltages occur in addition to the measuring voltage and therefore either lead to an increased measuring current and hence to increased response sensitivity or result in lower measuring current what means that tripping is prevented. In order to avoid this, insulation monitoring devices using a pulsed measuring voltage in compliance with IEC 61557-8:2007-02 should be used.

Protection of the isolating transformer against overload and overtemperature In order to protect the transformer and the connecting leads between the primary and secondary terminals and the distribution bus against overload and overtemperature, the standard, section 710.413.1.5, recommends to monitor the load and temperature of the transformer. Thereby a visual and acoustic alarm is issued when the permissible load current and/or temperature are exceeded. For monitoring, a combination of temperature monitoring (PTC thermistors in the winding of the transformer) and current monitoring are utilized in order to detect both a gradual heating of the transformer as well as the occurrence of a transient load when connecting high-capacity electrical equipment (Figure 2):

Figure 2: Insulation Monitor A-ISOMETER 107TD47

Information for medical/technical staff Thanks to insulation, load and temperature monitoring the medical staff is informed at an early stage, before a critical state in the power supply occurs. The following conditions are monitored and reported to the user by an alarm indicator and test combination: 1. 2. 3. If a faulty piece of equipment is plugged in, the system will detect the insulation fault and issue an alarm alerting the user to unplug the equipment and have it repaired. Should excessive load be placed on the system, it will display the increasing load and will sound an alarm as the load approaches 100%. Should an overload or fault cause the transformer temperature to rise above normal levels an alarm indicates the problem.

The information is indicated by an alarm indicator and test combination at a suitable place in the medical location (section 710.413.1.5) so that it can be permanently monitored (audible and visual signals) by the medical staff (normal operation: green LED, alarm: yellow LEDs). (Figure 3).

Figure 3: Alarm and test combination MK2007 displaying insulation resistance and transformer load.

Figure 4: IT system with insulation monitoring in operating rooms

Insulation fault location systems for ICUs In intensive care units, it is advantageous to use insulation fault location systems. The demand for an insulation fault location system arises from the standard IEC 60364-4-41:2005-12. 411.6.3.1 In cases where an IT system is used for reasons of continuity of supply, an insulation monitoring device shall be provided to indicate the occurrence of a first fault from alive part to exposed-conductive-parts or to earth. This device shall initiate an audible and/or visual signal which shall continue as long as the fault persists. NOTE 1 It is recommended that a first fault be eliminated with the shortest practicable delay. ation monitoring device shall be provided to indicate the occurrence of a first fault from a D Standard-compliance is not the only reason why insulation fault location systems are recommended to be used in intensive care units: A large number of socket-outlets is installed in an intensive care room so that the detection of defective devices or faulty circuits involves a lot of time and costs. Often, the intensive care bed cannot be used during fault location, since devices which support vital body functions have to be disconnected. Available personnel resources do not allow immediate fault location.

Figure 5: Medical IT system including an insulation fault location system in an intensive care unit

Safety in case of power supply failure According to 710.556.5.2.2.1 In the event of a voltage failure of one or more line conductors at the distribution board, a special safety power supply source shall maintain: luminaries of operating theatre tables; other essential luminaries, e.g. endoscopes; critical life-supporting medical electrical equipment for a minimum period of 3 h.

It shall restore the supply within a change-over period not exceeding 0,5 s. The duration of 3 h may be reduced to 1 h if a power source according to 710.556.5.2.2.2 is installed and the essential luminaries for operation can be supplied from this source. Equipment according to 710.556.7.5 and 710.556.8 shall be connected within 15 s to a safety power supply source capable of maintaining it for a minimum period of 24 h, when the voltage of one or more line conductors at the main distribution board for the safety services has decreased by more than 10 % of the nominal value of supply voltage and of a duration greater than 3 s. escape routes; lighting of exit signs;

locations for switchgear and controlgear for emergency generation sets and for main distribution boards of the normal power supply and for power supply for safety services; rooms in which essential services are intended. In each room at least one luminaire shall be supplied from the power source for safety services; rooms of group 1 medical locations. In each room at least one luminaire shall be supplied from the power supply source for safety services; rooms of group 2 medical locations. A minimum of 50 % of the lighting shall be supplied from the power source for safety services.

The duration of 24 h can be reduced to a minimum of 3 h if the medical requirements and the use of the location, including any treatment, can be concluded and if the building can be evacuated in a time which is well within 24 h.

Figure 6: Example of a power supply for medical locations in accordance with IEC 60364-7-710

Summary The requirements for electrical safety in medical locations are stipulated in the internationally applied standard IEC 60364-7-710. The application of the appropriate equipment solutions ensures a comprehensive protection of patients and medical staff.

Literature: [1] IEC 60364-7-710:2002-11 Electrical installations of buildings Part 7-710: Requirements for special installations or locations Medical locations IEC 60364-4-41: 2005-12 Electrical installations of buildings Part 4: Protection for safety Chapter 41: Protection against electric shock IEC 61557-8: 2007-01 Electrical safety in low voltage distribution systems up to AC 1000 V and DC 1500 V Equipment for testing, measuring or monitoring of protective measures Part 8: Insulation monitoring for IT systems IEC 61557-9:1999-09 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. Equipment for testing, measuring or monitoring of protective measures - Part 9: Equipment for insulation fault location in IT systems

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Author: Ulrich Lampe Export Manager Dipl.-Ing. W. Bender GmbH&Co.KG Londorfer Strasse 65 35305 GRUENBERG GERMANY www.bender-de.com